Use of Hair to Diagnose Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00419679|
Recruitment Status : Unknown
Verified January 2007 by Fermiscan Ltd.
Recruitment status was: Recruiting
First Posted : January 9, 2007
Last Update Posted : January 9, 2007
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Procedure: x-ray diffraction of human hair||Phase 1 Phase 2|
The test has the potential to improve the diagnostic (and consequently therapeutic) paradigm for breast cancer.
Women attending a radiology clinic in the Mater Hospital, Sydney, for a mammogram will be invited to participate in the study. A few hairs will be cut from their head or pubic region, put into a coded container and sent to the sponsor for analysis by synchrotron-x-ray diffraction. Although an imperfect standard for a variety of reasons, mammography is the standard screening assay, and confirmation of the pathology of the lesions found by mammography is carried out by biopsy. This will be the standard to which the hair test results will be compared. A negative mammogram will confirm a negative hair test, but a negative mammogram combined with a positive hair diffraction test will need a different approach. In the event of a positive hair test and a negative second read of the mammogram, the patient will be contacted by the referring practitioner. Patients in this category will be offered a breast MRI. A negative breast MRI under these circumstances will be classified as a true negative.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3600 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Prospective Blinded Study to Evaluate and Characterise an Assay for the Diagnosis of Breast Cancer Using Synchrotron-Derived X-Ray Diffraction of Hair Fibres.|
|Study Start Date :||December 2006|
- The primary outcome is the determination of the accuracy (sensitivity and specificity) of the x-ray diffraction test for breast cancer using hair. Sensitivity is defined as the proportion of all positive Fermiscan tests that are true positives.
- The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419679
|Contact: Peter French, BSc, MSc, PhDfirstname.lastname@example.org|
|Contact: Gary Corino, BScemail@example.com|
|Australia, New South Wales|
|The Mater Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2065|
|Contact: Phillip Yuile, MBBS (Hons), FRNZCR +61299292600 firstname.lastname@example.org|
|Principal Investigator:||Phillip Yuile, MBBS (Hons), FRNZCR||The Mater Hospital, Sydney|